Digestive Health Matters - Treatment News
Solesta is now Fully Available in the U.S.
September 5, 2011
(September 6, 2011) Oceana Therapeutics today announced the U.S. launch of Solesta, a significant new treatment option offering patients with fecal (bowel) incontinence an opportunity for restored confidence to pursue a more normalized lifestyle. The Food and Drug Administration (FDA)... Read More

 
Ironwood and Forest Announce Submission of New Drug Application for Linaclotide for the Treatment of Irritable Bowel Syndrome with Constipation and Chronic Constipation
August 8, 2011
August 9, 2011 – Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of... Read More

 
InterStim Therapy for Bowel Control Receives FDA Approval
March 31, 2011
April 1, 2011 – Medtronic, Inc. today announced US Food and Drug Administration (FDA) approval of InterStim® Therapy for Bowel Control. InterStim Therapy, previously available to treat the symptoms of overactive bladder and non-obstructive urinary retention, is now also approved... Read More

 
FDA Delays Approval Consideration of Rifaximin
March 8, 2011
March 8, 2011 - Salix Pharmaceuticals confirmed that the U.S. Food and Drug Administration (FDA) wants more information about rifaximin. The FDA is not ready to grant a new marketing approval for rifaximin for the treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related... Read More

 
Rifaximin Shows Promise for Treatment on Non-Constipated IBS
January 6, 2011
Results from two Phase 3 clinical trials involving 1,260 non-constipated male and female patients with irritable bowel syndrome (Non-C IBS) were reported in the January 6, 2011 issue of the New England Journal of Medicine (NEJM) showing adequate relief of IBS symptoms, bloating, abdominal pain,... Read More

 
Application Filed for New Treatment for Incontinence
December 2, 2010
On April 12, 2010 Oceana Therapeutics and Q-MedAB announced the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta® for the treatment of Bowel Incontinence, a largely unsatisfied medical need afflicting millions of Americans. The... Read More

 
Results Positive from Phase 3 Trials of Linaclotide for Treatment of Patients with IBS-C
October 31, 2010
On November 1, 2010 Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. announced positive top-line results from the second of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with... Read More

 
Linaclotide Shows Promise as a Treatment for Patients with Chronic Constipation
May 2, 2010
Positive results from Phase 3 clinical trials assessing the efficacy and safety of linaclotide in patients with chronic constipation were reported on May 3, 2010 at the annual meeting of Digestive Disease Week (DDW). Read More

 
FDA Gives Marketing Approval for Metozolv™ ODT (Orally Disintegrating Tablets)
September 7, 2009
The FDA has granted marketing approval for the drug metoclopramide (Metozolv ODT) 5mg and 10 mg orally disintegrating tablets. The drug, marketed by Salix Pharmaceuticals, is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults and the... Read More